Status:
COMPLETED
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Lead Sponsor:
University of Cincinnati
Conditions:
Brain Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after r...
Detailed Description
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. F...
Eligibility Criteria
Inclusion
- Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
- Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
- Age \> 18 years
- Partial or total resection of a metastatic tumor are eligible
Exclusion
- Known sensitivity to vitamin E or Trental
- Recent intracranial bleed or retinal hemorrhage
- Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
- History of Avastin treatment
- Anticipated need for treatment with Avastin
- History of bleeding disorder
- History of liver disorder
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01508221
Start Date
June 1 2011
End Date
February 1 2017
Last Update
September 14 2023
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219